Light Therapy and Binge Eating Disorder Treatment (BED Light Study)

Binge-Eating Disorder Clinical Trial

Official title:

Interest of Light Therapy in the Treatment of Binge Eating Disorder: Prospective Controlled Randomized Double-blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03094260
• Other study ID #: 69HCL16_0626
• Secondary ID: 2016-A01768-43
• Status: Completed
• Phase: N/A
• Start date: March 29, 2018
• Est. completion date: April 9, 2020

Study information

• Verified date: June 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Binge Eating Disorder (BED) is the most widespread food behavior disorder, with prevalence three times higher than anorexia. Its pathophysiology remains poorly understood and the investigators have few therapeutic options. Following a review of the literature, the investigators hypothesize that luminotherapy could be an innovative treatment of BED by its favorable effect on triggers of hyperphagic access, circadian disturbances, attention and impulsivity. The study is prospective, interventional, randomized, double-blind, monocentric (HCL). 52 patients with BED will be randomized to an active arm with intensive luminotherapy (1 daily 30 min, 10,000 lux in the morning) versus a placebo arm (<500 lux). Treatment will be delver every day during 30 days. Assessments will take place on D0, D30 and D60. The main objective is to compare the evolution of the number of hyperphagic access before and after treatment between the two groups. Secondary objectives are to compare characteristics of hyperphagic access, bodily concerns, food dependence and impulsivity, mood, anxiety, cognitive and attentional profiles (STROOP, Go / No Go, SST, BART, Prospective Time Estimation Task, Switching Task), liking / wanted for different food categories and carbohydrate metabolism (CRP, glucose, insulinemia, insulin resistance, profile of lipid abnormalities, 25-OH vitamin D3).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 9, 2020
• Est. primary completion date: April 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Aged between 18 and 55 years old

• Binge eating disorders or other eating disorders according to DSM V criteria

• Patient with BES score (with " Bing Eating Scale " ) > 18

• Patient with BMI > 18.5 kg/m2

• Patient who agrees to be included in the study and who signs the informed consent form

• Patient affiliated to a healthcare insurance plan

Exclusion Criteria:

• Patients with other psychiatric comorbidities, including a disorder bipolar mood

• Unstabilized diabetic patient with or retinopathy

• Patient with sleep disorder (delay or phase inversion)

• Patient with psychotropic treatment unstabilized (except anxiolytic treatment)

• Recent eye surgery or eye problem preventing exposure to bright light.

• Medication making the skin more sensitive to light (eg. Tablets against malaria)

• Patient who does not understand French/is unable to give consent

• Mentally unbalanced patients, under supervision or guardianship

• Patient already included in a research study

• Pregnancy or desire to be pregnant during the study

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders

Intervention

Device:
• High intensity bright light therapy
Treatment with light therapy in high intensity (10,000 lux), daily for 30 days between 6 am and 9 am for 30 minutes. Le device is placed at arm's length (at approximately 50-75cm from the eyes) within the field of vision. The light must bathe the face To ensure the light reaches your eyes, this appliance has a stand that can be set to a variable angle. If subject is sitting higher or standing and the top edge of the appliance is below eye level, the appliance will be placed in a tilted position so that its light points further upwards and reaches the eyes. If subject is sitting at a table or desk and the top edge of the appliance is above eye level. The appliance can be placed in a more upright position.
• Low intensity light therapy
Treatment with light therapy in low intensity (<500 lux), daily for 30 days between 6 am and 9 am for 30 minutes. Le device is placed at arm's length (at approximately 50-75cm from the eyes) within the field of vision. The light must bathe the face To ensure the light reaches your eyes, this appliance has a stand that can be set to a variable angle. If subjectis sitting higher or standing and the top edge of the appliance is below eye level, the appliance will be placed in a tilted position so that its light points further upwards and reaches the eyes. If subject is sitting at a table or desk and the top edge of the appliance is above eye level. The appliance can be placed in a more upright position.

Locations

Country	Name	City	State
France	HCL Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon)	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and discontinuation of treatment	The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day	Day-7 to Day-1 period (before Day 0) compared to Day23 to Day30 period (after Day 0)
Secondary	Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and 30 days after discontinuation of treatment	The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day	Day-7 to Day-1 period compared to Day23 to Day30 period
Secondary	Characteristics of hyperphagic access (severity of the disorder)	Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.	Day 0
Secondary	Characteristics of hyperphagic access (severity of the disorder)	Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.	Day 30
Secondary	Characteristics of hyperphagic access (severity of the disorder)	Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.	Day 60
Secondary	Characteristics of hyperphagic access (duration of crisis)	Evaluation of the duration,by the crisis agenda.	Day 0
Secondary	Characteristics of hyperphagic access (duration of crisis)	Evaluation of the duration,by the crisis agenda.	Day 30
Secondary	Characteristics of hyperphagic access (duration of crisis)	Evaluation of the duration,by the crisis agenda.	Day 60
Secondary	Characteristics of hyperphagic access (amount of food ingested )	Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.	Day 0
Secondary	Characteristics of hyperphagic access (amount of food ingested )	Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.	Day 30
Secondary	Characteristics of hyperphagic access (amount of food ingested )	Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.	Day 60
Secondary	Characteristics of hyperphagic access ( evolution of factors triggering)	Evaluation of the factors triggering by the "START" scale.	Day 0
Secondary	Characteristics of hyperphagic access ( evolution of factors triggering)	Evaluation of the factors triggering by the "START" scale.	Day 30
Secondary	Characteristics of hyperphagic access ( evolution of factors triggering)	Evaluation of the factors triggering by the "START" scale.	Day 60
Secondary	Characteristics of hyperphagic access (severity of the disorder, duration of crisis, amount of food ingested and evolution of factors triggering)	Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale. Evaluation of the duration, the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda. Evaluation of the factors triggering by the "START" scale.	Day 30
Secondary	Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and 30 days after discontinuation of treatment	The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day	Day-7 to Day-1 period (before Day 0) compared to Day53 to Day60 period (after Day 0)
Secondary	Symptomatic development of BED	The symptomatic development of BED will be measured by evaluating : The psychopathology of the BED from the Eating Disorder Inventory 2 questionnaire; The Body concerns based on the "Body sharpe" questionnaire; The Addiction to food from the Yale Food Addiction scale; The Diet-related impulsivity from the Three-Factor Eating Questionnaire	Day 0
Secondary	Symptomatic development of BED	The symptomatic development of BED will be measured by evaluating the composite: The psychopathology of the BED from the Eating Disorder Inventory 2 questionnaire; The Body concerns based on the "Body sharpe" questionnaire; The Addiction to food from the Yale Food Addiction scale; The Diet-related impulsivity from the Three-Factor Eating Questionnaire	Day 30
Secondary	Symptomatic development of BED	The symptomatic development of BED will be measured by evaluating the composite: The psychopathology of the BED from the Eating Disorder Inventory 2 questionnaire; The Body concerns based on the "Body sharpe" questionnaire; The Addiction to food from the Yale Food Addiction scale; The Diet-related impulsivity from the Three-Factor Eating Questionnaire	Day 60
Secondary	Evolution of other psychological parameters related to BED	The evolution of other psychological parameters will be measured by evaluating the composite :the mood from the Beck Depression Inventory scale, the anxiety from the "State Trait Anxiety Inventory or STAI-Y" scale, the clinical impulsivity from the "UPPS-P shortcut" scale	Day 0
Secondary	Evolution of other psychological parameters related to BED	The evolution of other psychological parameters will be measured by evaluating the composite the mood from the Beck Depression Inventory scale, the anxiety from the "State Trait Anxiety Inventory or STAI-Y" scale, the clinical impulsivity from the "UPPS-P shortcut" scale	Day 30
Secondary	Evolution of other psychological parameters related to BED	The evolution of other psychological parameters will be measured by evaluating the composite mood from the Beck Depression Inventory scale, the anxiety from the "State Trait Anxiety Inventory or STAI-Y" scale, the clinical impulsivity from the "UPPS-P shortcut" scale	Day 60
Secondary	Evolution of attentional cognitive profiles and impulsivity	The evolution of attentional and impulsive cognitive profiles will be measured from a computerized neurocognitive test battery whose order will be randomly fixed. The tests will be STROOP, The Go / No Go, The Stop Signal Task, The Balloon Analog Risk Task, The Prospective Time Estimation Task, The Set Switching Task	Day 0
Secondary	Evolution of attentional cognitive profiles and impulsivity	The evolution of attentional and impulsive cognitive profiles will be measured from a computerized neurocognitive test battery whose order will be randomly fixed. The tests will be STROOP, The Go / No Go, The Stop Signal Task, The Balloon Analog Risk Task, The Prospective Time Estimation Task, The Set Switching Task	Day 30
Secondary	Evolution of attentional cognitive profiles and impulsivity	The evolution of attentional and impulsive cognitive profiles will be measured from a computerized neurocognitive test battery whose order will be randomly fixed. The tests will be STROOP, The Go / No Go, The Stop Signal Task, The Balloon Analog Risk Task, The Prospective Time Estimation Task, The Set Switching Task	Day 60
Secondary	Evolution of appetite for different categories of food	The evolution of appetite for different categories of food will be measured from a computerized task: the Leed Food Preference Questionnaire (LFPQ). A description of the test is available at: https://www.millisecond.com/download/library/	Day 0
Secondary	Evolution of appetite for different categories of food	The evolution of appetite for different categories of food will be measured from a computerized task: the Leed Food Preference Questionnaire (LFPQ). A description of the test is available at: https://www.millisecond.com/download/library/	Day 30
Secondary	Evolution of appetite for different categories of food	The evolution of appetite for different categories of food will be measured from a computerized task: the Leed Food Preference Questionnaire (LFPQ). A description of the test is available at: https://www.millisecond.com/download/library/	Day 60
Secondary	Biological parameters may be impacted or mediated by part of the treatment efficiency	Inflammation parameters, glucose, insulinemia, insulin resistance, Profile of lipid abnormalities, 1-25-OH vitamin D3	Day 0
Secondary	Biological parameters may be impacted or mediated by part of the treatment efficiency	Inflammation parameters, glucose, insulinemia, insulin resistance, Profile of lipid abnormalities, 1-25-OH vitamin D3	Day 30
Secondary	Weight (kilogramm)	Weight will be expressed in absolute value	Day 0
Secondary	Weight (kilogramm)	Weight will be expressed in absolute value	Day 30
Secondary	Weight (kilogramm)	Weight will be expressed in absolute value	Day 60
Secondary	Observance rate to light therapy	The assessment of the adherence rate will be quantified by the average number of lux received over the 30 days of treatment. The exposure (expressed in lux number / session) in lux will be measured and recorded using a luxmeter	day1 to day30